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Идёт набор NCT06643247

Electroacupuncture Regulation of Immune Cells in Herpes Zoster

Без фазы С лечением Herpes Zoster Electroacupuncture Immune

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Drug, Electroacupuncture.
Кому может быть актуально
Состояния в реестре: Herpes Zoster, Electroacupuncture, Immune. Базовые параметры: 50 лет — 70 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

The Regulatory Mechanisms of Electroacupuncture Intervention on Immune Cells in Herpes Zoster

Обзор

Herpes Zoster (HZ), caused by the Varicella-Zoster Virus (VZV), is a common infection characterized by localized pain and blistering, with higher incidence in females. HZ affects patients' physical health, mental well-being, and quality of life. The immune system is critical in HZ pathogenesis. Studies show acupuncture relieves pain, modulates immunity, and may lower postherpetic neuralgia (PHN) risk. However, evidence is limited on whether electroacupuncture (EA) alleviates HZ by modulating immune cells. Using mass cytometry (CyTOF), this study will analyze peripheral immune cell changes pre- and post-EA to explore its regulatory effects on HZ immunity. This study will recruit HZ patients and healthy controls (HC), dividing patients into medication-only and medication+EA groups to assess EA's potential immunomodulatory effects in HZ treatment.

Подробное описание

The study will enroll 8 HZ patients who meet the inclusion criteria and 3 age- and gender-matched healthy controls (HC). HZ patients will be randomly assigned in a 1:1 ratio to a medication-only group or a medication plus electroacupuncture group. All participants will receive Valacyclovir Hydrochloride tablets and Mecobalamin tablets. HZ-related immune cells in peripheral blood will be analyzed using CyTOF before treatment (day 0), during treatment (day 4), and after treatment (day 7). Pain intensity and characteristics will be assessed using the Visual Analogue Scale (VAS) and the Douleur Neuropathique 4 (DN4) questionnaire. Lesion healing (time to vesicle cessation, crusting, and scab detachment) and adverse events will also be recorded to evaluate lesion regression in HZ patients.

Вмешательства

  • Препарат Drug
    1\) Valacyclovir Hydrochloride tablets, 0.3 g per dose, twice daily; 2) Mecobalamin tablets, 0.5 mg, three times daily. Taken continuously for 7 days.The affected skin is kept clean and protected to maintain lesion integrity.
  • Процедура Electroacupuncture
    Electroacupuncture Treatment: Needling acupoints include the Jiaji points corresponding to the spinal nerve segment of the affected area, Ashi acupoints along the affected zone, and bilateral Hegu and Waiguan points. Electroacupuncture will be performed once daily for 30 minutes per session, with a total of 7 consecutive sessions. The Jiaji and Ashi acupoints will be connected to an electroacupuncture device, set to disperse-dense wave stimulation at a frequency of 2/100 Hz, with current intensi

Первичные конечные точки

  • Peripheral blood immune cell levels [Срок оценки: Before (Day 0), during (Day 4) and after (Day 7) treatment.]
Вторичные конечные точки (4)
  • Visual Analogue Scale [Срок оценки: Before treatment (Day 0) and after each treatment (Day 1- Day 7).]
  • Douleur Neuropathique 4 questions [Срок оценки: Before treatment (Day 0) and after each treatment (Day 1- Day 7).]
  • Lesion Regression Time [Срок оценки: Before treatment (Day 0) and after each treatment (Day 1- Day 7).]
  • Occurrence of adverse reactions [Срок оценки: During the intervention.]

Критерии участия

Inclusion Criteria for HZ:

  • Meets HZ diagnostic criteria;
  • Female, aged between 50 and 70 years;
  • Disease duration ≤7 days, with no prior antiviral, analgesic, or other treatments;
  • Herpetic lesions limited to the trunk, within 1 to 3 dermatomes;
  • Willing to participate in the trial and has signed the informed consent form.

Inclusion Criteria for HC:

  • No history of HZ or major cardiovascular, respiratory, digestive, urinary, hematologic, endocrine, or neurological diseases;
  • Age-matched female HC volunteers for the HZ group;
  • Clear consciousness and ability to communicate normally;
  • Fully understands the study protocol, demonstrates good compliance, and is willing to cooperate with the study;
  • Has signed a written informed consent form.

Критерии исключения

  • Special types of herpes zoster, including ophthalmic, otic, visceral, meningeal herpes zoster, and zoster sine herpete;
  • Women who are planning to conceive, pregnant, or breastfeeding;
  • Patients with severe primary diseases of the circulatory, respiratory, or endocrine systems, or systemic failure;
  • Patients with bleeding tendencies;
  • Use of corticosteroids or immunosuppressants within the past month.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • The Affiliated Hangzhou First People's Hospital — Ханчжоу

Идентификаторы

NCT: NCT06643247 · ZN-2024349-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗